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Evaluation of pregnancy outcome records in the German Pharmacoepidemiological Research Database (GePaRD)

Authors

  • RT Mikolajczyk,

    Corresponding author
    1. Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
    2. Helmholtz Centre for Infection Research, Braunschweig, Germany
    • Medical School Hannover, Hannover, Germany
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  • AA Kraut,

    1. Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
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  • E Garbe

    1. Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
    2. Faculty of Human and Health Sciences, University of Bremen, Bremen, Germany
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  • The preliminary results from this study were presented at the workshop of the AGENS group [Working group for the use of secondary data of the German Epidemiological Society], 22.03.–23.05.2012 in Bremen.

Correspondence to: Rafael Mikolajczyk, Department of Epidemiology, Helmholtz Centre for Infection Research Inhoffenstr. 7, 38124 Braunschweig, Germany. E-mail: rafael.mikolajczyk@helmholtz-hzi.de

ABSTRACT

Purpose

Routine health care data are a valuable source for the assessment of risks of drugs during pregnancy. Therefore, the aim of the current analysis was the evaluation of pregnancy outcome records in German health insurance data.

Methods

We used the German Pharmacoepidemiologic Research Database including data of more than 15 million insurants (about 18% of the German population). Among 10–49 year-old women, we identified six categories of pregnancy outcomes: term births, preterm births, stillbirths, induced abortions, spontaneous abortions and ectopic pregnancies. In order to assess the validity of these records, we have set our results in relation to representative data for the corresponding outcomes in Germany. We also investigated whether pregnancy markers (diagnoses, procedures or medical services which indicate an existing pregnancy) can be used to identify pregnancies.

Results

In total, we identified 94 261 pregnancy outcomes in 2005. The percentage of births outside hospital (1.2%) and of preterm births (11.6%), the rate of stillbirths (3 per 1000 live births) and the rate of ectopic pregnancies (20 per 1000 live births) agreed well with representative data for Germany. Compared to epidemiological data, the occurrence of spontaneous abortions was underestimated (5.4% of all pregnancies). There were 4.1 induced abortions per 100 live births, compared to 18.1 in national data. Positive predictive values and sensitivities of markers varied across marker categories and for different pregnancy outcomes.

Conclusions

Completeness of pregnancy outcomes recorded in the database varied by pregnancy outcome. This should be taken into account in studies of drug safety in pregnancy. Copyright © 2013 John Wiley & Sons, Ltd.

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